SK Bioscience "Typhoid Conjugate Vaccine, Successful Phase 2 Clinical Trial for Additional Vaccination in Infants and Young Children"

Jointly Developed with International Vaccine Institute 'NBP618'
64-Fold Increase in Antibody Levels After Additional Vaccination in Infants Aged 6-23 Months
Phase 3 Global Clinical Trial Proves Safety for Under 45
Awaiting MFDS Approval... Plans to Obtain WHO PQ Certification

An SK Bioscience researcher is conducting vaccine research.

[Asia Economy Reporter Lee Gwan-joo] SK Bioscience announced that the excellent clinical results of the typhoid conjugate vaccine, which is being developed in collaboration with international organizations aiming for global supply, have been consecutively published in international academic journals.

SK Bioscience stated on the 28th that the Phase 2 clinical trial results of the booster shot (second dose) of the typhoid vaccine candidate 'NBP618,' jointly developed with the International Vaccine Institute (IVI), were published in the January online issue of the international academic journal 'npj (nature partner journal) Vaccine.' 'npj Vaccine' is a sister journal of the internationally renowned scientific journal 'Nature' and holds high prestige in the vaccine field.

The published clinical results provide data on the immune response following booster shot administration in infants aged 6 to 23 months. This is part of the Phase 2 clinical study of NBP618 jointly conducted by SK Bioscience, IVI, and the Research Institute for Tropical Medicine (RITM) in Manila, Philippines, from April 2018 to October 2020. Until now, the vaccination effects of typhoid vaccines in children under five years old have not been sufficiently known.

The research team led by Dr. Birkneh Tilahun Tadesse of IVI analyzed the immune response after administering the NBP618 booster shot to 285 infants aged 6 to 23 months. They confirmed that when the booster shot was given 27.5 months after the primary vaccination, antibody levels in the body increased approximately 64-fold compared to before the booster, inducing a strong immune response.

Experts analyze that these results represent a significant advancement in typhoid prevention. According to IVI, since more than half of typhoid infections occur in children under five years old, this study investigating the effects of the typhoid conjugate vaccine in infants is expected to play a key role in protecting young children in countries where typhoid is prevalent.

NBP618 is a typhoid vaccine being developed by SK Bioscience and IVI using conjugate vaccine production technology. The conjugate vaccine technology involves linking the polysaccharides of the typhoid bacteria to carrier proteins such as diphtheria toxoid, a platform technology that has been used in pneumococcal vaccines and others. Unlike existing oral live vaccines or polysaccharide vaccines, which are ineffective in children under five years old, the conjugate vaccine can be administered to infants aged 6 months to 2 years.

Previously, in December last year, the global Phase 3 clinical trial results of NBP618, conducted on over 1,800 healthy individuals aged 6 months to under 45 years, were published in 'The Lancet Infectious Diseases,' a sister journal of the world-renowned medical journal The Lancet and the most authoritative journal in infectious diseases. NBP618 induced immunogenicity equivalent to that of existing typhoid conjugate vaccines that have obtained WHO PQ (Pre-Qualification) certification. Additionally, no significant adverse effects were observed across all age groups during the clinical trials, demonstrating safety. Based on these clinical results, SK Bioscience has completed the application for export product approval of NBP618 with the Ministry of Food and Drug Safety and plans to pursue WHO PQ certification to facilitate active use of NBP618 in developing countries.

SK Bioscience President Ahn Jae-yong said, “NBP618 has proven its efficacy and safety not only in adults but also in infants under five years old, who are particularly vulnerable to infection, through global clinical trials, making it an excellent solution for countries suffering from typhoid.” He added, “We will continue to collaborate with various global organizations to prevent various viral infectious diseases threatening human health and realize our value as a vaccine company.”

This content was produced with the assistance of AI translation services.